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Acadia Pharmaceuticals Inc. ACAD announced top-line data from a phase II study evaluating its investigational candidate, ACP-044, for the treatment of acute pain following bunionectomy surgery.
The double-blind, placebo-controlled phase II study evaluated the safety and efficacy of ACP-044 for the given indication. The study failed to meet the primary endpoint, which was a comparison of cumulative pain intensity scores over 24 hours between the once daily ACP-044 (1600 mg), four times daily ACP-044 (400 mg) and placebo treatment arms.
Per the company, a favorable trend was observed on the primary endpoint in the ACP-044 (400 mg) once every six hours treatment group. Despite showing consistent improvement from placebo, these trends were not statistically significant at 48 hours and 72 hours.
Shares of Acadia were down 5.4% in after-hours trading on Monday following the announcement of the news. The stock has declined 4% so far this year compared with the industry’s decrease of 13.4%.
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In March 2021, the company initiated a phase II study on ACP-044 for treating postoperative pain following bunionectomy surgery.
Acadia is also evaluating ACP-044 in an ongoing study for treating pain associated with osteoarthritis. The study is expected to complete in the first half of 2023.
Acadia has other promising pipeline candidates that are progressing well.
In December 2021, the company announced positive top-line data from the phase III Lavender study, which evaluated the safety and efficacy of its candidate, trofinetide, for the treatment of Rett syndrome. The study met its co-primary endpoints.
Acadia expects to file a new drug application for trofinetide to treat Rett syndrome around mid-2022.
Acadia’s sole marketed drug, Nuplazid (pimavanserin), is approved in the United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Acadia has resubmitted the supplemental new drug application (sNDA) to the FDA for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (“ADP”) in February 2022. With this resubmission of the sNDA for pimavanserin, the company is now narrowing down the focus of the proposed indication from dementia-related psychosis to ADP. The FDA has set a target action date of Aug 4, 2022.
In 2021, Nuplazid recorded sales worth $484.1 million, reflecting an increase of 10% year over year. A potential label expansion is likely to boost sales of the drug in 2022 and beyond.
Zacks Rank & Stocks to Consider
Acadia currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Aligos Therapeutics, Inc. ALGS, Applied Therapeutics, Inc. APLT and Voyager Therapeutics, Inc. VYGR, all carrying the same Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Aligos Therapeutics’ loss per share has narrowed 15.1% for 2022 and 45.7% for 2023 over the past 60 days.
Earnings of ALGS surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Applied Therapeutics’ loss per share estimates have narrowed 35.8% for 2022 and 32.7% for 2023 over the past 60 days.
Earnings of Applied Therapeutics have surpassed estimates in two of the trailing four quarters, met the same once and missed the same on the other occasion.
Voyager Therapeutics’ loss per share estimates have narrowed 38.6% for 2022 and 29% for 2023 over the past 60 days. The VYGR stock has skyrocketed 232.4% year to date.
Earnings of Voyager Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
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